Colonoscopy Clinical Trial
Official title:
Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps
Verified date | May 2010 |
Source | Soon Chun Hyang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
Several novel imaging technologies are currently used for detection and differentiation of
colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan
(Pentax).
Several previous studies have indicated that NBI without magnification can be useful for
real-time differentiation of diminutive colonic neoplasias.
To date, however, there are no studies comparing NBI with other imaging systems (FICE or
i-Scan) for differentiation of diminutive colonic polyps.
The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in
real-time prediction of diminutive colonic polyps.
In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will
be observed with conventional colonoscopy, thereafter will be observed with new imaging
systems.
Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by
reference to histological results obtained by endoscopic biopsy or polypectomy.
Status | Completed |
Enrollment | 142 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - screening or surveillance colonoscopy - age over 18 - informed consent Exclusion Criteria: - history of inflammatory bowel diseases - history of hereditary colorectal cancers and polyposis syndrome - inability to give informed consent - use of antiplatelet agent and anticoagulants - pregnancy |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Soon Chung Hyang University, Cheonan hospital | Cheonan | Choongnam |
Lead Sponsor | Collaborator |
---|---|
Soon Chun Hyang University |
Korea, Republic of,
Hoffman A, Kagel C, Goetz M, Tresch A, Mudter J, Biesterfeld S, Galle PR, Neurath MF, Kiesslich R. Recognition and characterization of small colonic neoplasia with high-definition colonoscopy using i-Scan is as precise as chromoendoscopy. Dig Liver Dis. 2010 Jan;42(1):45-50. doi: 10.1016/j.dld.2009.04.005. Epub 2009 May 26. — View Citation
Rastogi A, Pondugula K, Bansal A, Wani S, Keighley J, Sugar J, Callahan P, Sharma P. Recognition of surface mucosal and vascular patterns of colon polyps by using narrow-band imaging: interobserver and intraobserver agreement and prediction of polyp histology. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):716-22. doi: 10.1016/j.gie.2008.09.058. — View Citation
Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic efficacy | Sensitivity, specificity, and diagnostic accuracy | about 1 year | No |
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